FDA, USP co-sponsors OTC drug products workshop

Updated public standards incorporating new tests for impurities as well as more modern technologies to help ensure the quality of over-the-counter (OTC) ingredients and products will be key areas of focus for a September 8-9, 2011, workshop co-sponsored by the U.S. Food & Drug Administration (FDA) and the U.S. Pharmacopeial Convention (USP).

In addition to providing updates on new standards for acetaminophen and diphenhydramine-two very commonly used OTC ingredients-the FDA-USP OTC Drug Substances and Drug Products Workshop will solicit feedback on broader activities that will impact the OTC segment of the pharmaceutical industry, including future priorities for products and ingredients that require modernized quality standards and a path forward for developing standards for categories of products not currently addressed by USP such as mouthwashes and medicated shampoos. Janet Woodcock, M.D., director of FDA's Center for Drug Evaluation and Research (CDER), will keynote the event.

The workshop is an extension of a joint initiative of FDA, USP and the Consumer Healthcare Products Association (CHPA) to modernize specific USP monographs for OTC products and ingredients by adding impurities/degradants tests where no tests exist and/or incorporating modern analytical techniques and technologies for those that are outdated by today's scientific standards. The effort is part of a larger USP initiative to modernize a significant subset of its written standards, or monographs, contained in its drug compendia, the United States Pharmacopeia-National Formulary (USP-NF). Drug and ingredient manufacturers marketing products, including OTC products, in the United States are required by law to adhere to existing USP-NF monographs. These standards are enforceable by FDA, and are also used in more than 130 countries around the world.

Under this initiative, FDA prioritized acetaminophen (pain and fever relief), diphenhydramine (antihistamine) and other ingredients for modernization, in part due to concerns regarding the toxicity of certain impurities (e.g., p-aminophenol in acetaminophen). USP has advanced work on these ingredient monographs, which, once final, will have widespread impact due to the ubiquity of products containing these ingredients. Among the areas USP would like feedback on is the process for revising the dosage form (finished drug product) monographs. For acetaminophen alone, USP currently has 37 individual monographs for various liquid and solid dosage forms.

"Prescription and many over-the-counter drugs are regulated differently under the law, but it is equally important for both categories of products to be of high quality, supported by up-to-date, scientifically sound public standards that all manufacturers must adhere to," said CDER Director Dr. Woodcock. "Over-the-counter medicines are unique in that they are heavily relied upon across the patient population, are often used without healthcare provider oversight, and are available in a wide variety of dosage forms. All these factors make updating public standards for these medicines-starting with those that are most widely used-all the more critical."

"Modernization of over-the-counter medicines and ingredients is an important public health activity, and it is one that will be optimally achieved through a robust partnership among regulators, industry and USP," said Karen Russo, Ph.D., vice president of small molecules at USP. "As we determine the most productive path forward for tackling these updates, we seek input that will allow us to proceed in the most efficient manner-in order to maximize the benefit to patient health. USP is considering a number of approaches for addressing dosage forms of these medicines, and how we proceed will impact industry significantly. This workshop is a critical way for us to solicit-and for industry, consumer groups and others to provide-the feedback we need."

In addition to Dr. Woodcock, day one of the workshop will feature opening remarks from Scott Melville, chief executive officer of CHPA and Roger Williams, M.D., chief executive officer of USP. During the day, attendees will get an overview of FDA's OTC drug monograph system, USP's OTC monographs, the larger USP monograph modernization initiative (and FDA's and CHPA's roles in this), and information on progress of FDA's priority monographs of acetaminophen and diphenhydramine. Day two of the workshop will focus on the future of USP monographs for OTC products, including FDA expectations, industry challenges and different approaches for monograph development to allow USP to keep current with advances in the industry. Impurities in OTC drugs will also be a major topic for the day.

Registration for the workshop is $595 for industry and $495 for academia, association and government, with discounts for groups, students and USP Expert Committee members. USP will host a pre-workshop course, "Understanding the USP Compendial Process: Monographs, General Chapters and General Notices," which is recommended for attendees who are not familiar with USP's standards-setting process. Bundled discount pricing is available for those who choose to take the course along with the workshop.

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